Efficacy of acupuncture versus sham acupuncture for postpartum depression disorder: Study protocol for a randomized controlled trial

Abstract

IntroductionThis trial aims to conduct a randomized controlled trial (RCT) to determine the efficacy of acupuncture for postpartum depression disorder (PPD) and also to explore the potentional mechanism on the effectiveness of acupuncture for PPD. MethodsA total of 74 patients with PPD will be recruited and randomly allocated to two groups: verum acupuncture group or sham acupuncture group. All patients will receive 24 treatments over an 8-week period. The primary outcome measurement is 17-item Hamilton Rating Scale (17-HAMD), and the secondary outcomes will be assessed using the Edinburgh Postnatal Depression Scale (EPDS) and the changes in gut microbiota. The 17-HAMD and EPDS will be evaluated before treatment and after 1, 2, 4, and 8 weeks of treatments, as well as 20-week follow-up. The fecal sample collections will be performed before and after 8 weeks treatment. The evaluators and data analysis will be blinded to group allocation. DiscussionThere are some RCTs investigating the effects of acupuncture for PPD, however, the quality of evidence is not “high”. Therefore, this study will be designed as a high-quality RCT protocol. ConclusionThe findings of the randomized and sham-controlled trial will demonstrate whether acupuncture therapy is effective and safe for patients with PPD, probably via regulating the gut microbiota dysfunction. These findings may have an important impact on the practice of acupuncture for patients with PPD.